BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 23485326 · Received November 6, 2025

    Report

    Report Number
    3010457505-2025-00606
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 6, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE SKIN INFLAMMATION/IRRITATION CANNOT BE RULED OUT. MEDICAL DEVICE SITE REACTION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 16% AND 53% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 61-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) INITIATED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE PATIENT DEVELOPED A RASH ASSOCIATED WITH OPTUNE GIO THERAPY. THE RASH WAS UNRESPONSIVE TO TOPICAL CLOBETASOL AND DIPHENHYDRAMINE CREAM. IT RESOLVED FOLLOWING THE ADMINISTRATION OF DEXAMETHASONE, WHICH HAD ORIGINALLY BEEN PRESCRIBED ON (B)(6) 2024, FOR GAIT DISTURBANCE AND NAUSEA UNRELATED TO OPTUNE GIO THERAPY. DUE TO THE PERSISTENCE OF THE RASH, THE PATIENT WAS ADVISED TO INITIATE LOW-DOSE PREDNISONE THERAPY. PREDNISONE 10 MG WAS SUBSEQUENTLY PRESCRIBED. ON (B)(6) 2025, THE HEALTHCARE PROVIDER CONFIRMED THAT THE PATIENT HAD BEEN PRESCRIBED 5 MG OF PREDNISONE DAILY FOR THE MANAGEMENT OF SKIN IRRITATION ASSOCIATED WITH OPTUNE GIO THERAPY. THE PATIENT WAS ALSO RECEIVING BEVACIZUMAB AT THAT TIME AND CONTINUED OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552097 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention AMITRIPTYLINE| AMLODIPINE| ATORVASTATIN| CLOBETASOL| DEXAMETHASONE| EPINEPHRINE| HYDROXYZINE| LORAZEPAM| LOSARTAN| ONDANSETRON